Latest news with #REMS
The Hill
16 hours ago
- Politics
- The Hill
Trump can shatter the abortion pill cartel
The abortion pill is the only life-ending drug that does not require consultation or any assurance of accurate identifying information. In fact, for a drug that is intended to end a pregnancy, distributors do not even have to confirm pregnancy at all. Anyone not looking through the rose-colored glasses handed out by the abortion lobby can see this lack of regulation for what it clearly is: a recipe for rampant abuse. Several women have already come forward, sharing how their partner ordered the pill and drugged them, forcing abortions. Victims of sex trafficking have also come forward, recounting how they were forced to abort — often multiple times — by their captors, using the abortion pill. Somehow, these women go largely ignored by policymakers and those with the power to prevent future abuse. Abortion pill manufacturers and distributors have been allowed to form a cartel across and within the borders of the U.S. that has gone unchecked. Even those who pride themselves on giving women 'choice' should recognize there is no choice in such abuse. There is no consent in being forced to abort a wanted child. Abortion advocates' core pillar of 'autonomy' has been torn down to nothing more than rubble. As a nation, we attack the foreign cartels threatening the American people in many ways. But can we identify and shatter the ones we have allowed to form within our own borders? Since the Biden-era FDA used the COVID-19 pandemic as an excuse to remove the in-person dispensing requirement for the abortion drug mifepristone in 2021, abortion pill distributors have rapidly built their expansive cartel. Women and their abusers can access these cartel distributors online and are often required to fill out questionnaires that have no way to verify whether the alleged patient is actually the one behind the screen. Some of the questionnaires tied to these tele services ask you to confidentially verify your name and other personal identifying information. They even ask if you are being forced to order the pills. But what use are any of these questions when the abuser can easily circumvent the system and identify as the victim? In his first term, President Trump ordered one foreign abortion pill distributor to cease and desist illegal trafficking of abortion drugs not approved by the FDA into the U.S. Unfortunately, the administration did not follow through on its warning to the doctor in charge, and trafficking of the pill has only escalated. This term, the Trump administration has the opportunity and ability to send the abortion pill cartel packing. Most urgently, the Trump FDA can reinstate the in-person dispensing requirements for mifepristone. New data shows that by the end of 2024 one in four abortions were provided via 'telehealth,' demonstrating real and immediate impact reinstating REMS requirements would have. This unilateral administrative action can put a swift end to the domestic and criminal mail-order distribution of abortion pills. Although it will not prevent foreign cartel partners from sending the drugs into the country or in-person dispensing at brick-and-mortar abortion businesses, it is a first step. The Trump administration also needs to heighten scrutiny around mifepristone by working with the Department of Health and Human Services and the DEA to designate the drug as a controlled substance. Drugs with high potential for abuse and which may lead to psychological or physical damage are set to only be prescribed by certain licensed practitioners that hold DEA certifications — and mifepristone should not be an exception. Abuse of the abortion pill is rampant. Recent studies have shed further light on the expanded physical and psychological adverse events women are experiencing by taking mifepristone. Women being forced into abortion via the deregulation of the abortion pill are even more likely to experience these dangerous outcomes. The U.S. Code already creates heightened oversight and penalties for importation of controlled substances. If the Trump administration designates the abortion pill as a controlled substance, it will equip the Department of Justice to prosecute members of the cartel — both foreign and domestic — to the fullest extent of the law. Trump must also work alongside the Republican Congress to uphold state laws that prevent abortion pill trafficking. States such as Louisiana and Texas have laws in place that prohibit the abortion pill from being sent women within their borders, but it has been an uphill battle to enforce them, with pro-abortion states enacting shield laws to prevent prosecution of cartel abortionists engaging in pill trafficking. This term, Trump must hold true to abolish cartels — including the ones previous administrations have given free rein within our own borders. If Trump truly believes abortion to be a state issue, he should ensure that states have the power to protect their citizens. Women deserve to live without the paranoia that they might be the next victim of this dangerous cartel. Gavin Oxley is a public relations consultant currently serving at Americans United for Life.
Business Wire
27-06-2025
- Health
- Business Wire
U.S. Food and Drug Administration Approves Streamlined Patient Monitoring Requirements and Removal of REMS Programs within Bristol Myers Squibb's Cell Therapy Labels
PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved label updates for both of its CAR T cell therapies, Breyanzi ® (lisocabtagene maraleucel; liso-cel) for the treatment of large B cell lymphoma (LBCL) and other lymphomas and Abecma ® (idecabtagene vicleucel; ide-cel) for the treatment of multiple myeloma. These label updates reduce certain patient monitoring requirements and remove the Risk Evaluation and Mitigation Strategy (REMS) programs that had been in place since each product was initially approved. $BMY announces @US_FDA has approved removal of REMS and streamlined certain patient monitoring requirements for #CARTcelltherapy treatments. Share Despite the transformative potential of cell therapy, only about 2 in 10 eligible patients receive it, due to the confluence of complex logistical and geographic barriers affecting patients and providers. BMS is committed to a long-term goal of expanding access to cell therapy and supports today's class-wide label updates that will help ease known barriers to treatment and administration while maintaining patient safety. Across both labels, the FDA has approved the reduction or removal of specific patient monitoring requirements for Breyanzi and Abecma. These prolonged requirements posed burdens on healthcare delivery systems and for certain patients and their care partners, particularly those who live far from certified cell therapy treatment centers. The changes include: Driving restrictions reduced from 8 weeks to 2 weeks post treatment Requirement to stay within proximity of a healthcare facility following infusion reduced from 4 weeks to 2 weeks 'CAR T cell therapy is a transformational, potentially life-saving option for patients living with blood cancers, and we are working to challenge current practices, assumptions and barriers that limit access,' said Lynelle B. Hoch, president, Cell Therapy Organization, Bristol Myers Squibb. 'Today's FDA-approved label updates reinforce BMS' continued efforts to collaborate across the healthcare ecosystem, with the ultimate goal of reaching more patients and democratizing access to cell therapy.' The FDA has also approved removal of the REMS requirement from each product label. A REMS program is often required to help mitigate known or potential risks associated with new drugs or therapies. The FDA has since determined that the established management guidelines and extensive experience of the medical hematology/oncology community are sufficient to diagnose and manage the risks of side effects, including cytokine release syndrome (CRS) and neurologic toxicities (NTs), without a REMS for the class of CD19- and BCMA-directed autologous CAR T cell therapies. This change is likely to help further accelerate cell therapy into the community center setting. Together, these label updates reflect the growing body of clinical and real-world evidence underpinning the favorable efficacy and safety profile of CAR T cell therapy. To date, more than 30,000 patients have been treated with a CAR T cell therapy, with recent studies, including an analysis BMS presented earlier this month at the ASCO Annual Meeting, showing that the vast majority of serious adverse events (CRS and NTs) occur within the first two weeks of infusion. Following this announcement, BMS will work closely with the more than 150 treatment centers currently approved to administer Breyanzi and Abecma to remove the REMS programs. In parallel, BMS is focused on rapidly expanding the geographic footprint of cell therapy, with a renewed effort to add community cancer centers nationwide to administer Breyanzi and Abecma closer to patients, helping further reduce travel time and duration of stay away from home, family and work. "Living with blood cancer is challenging, but patients and their loved ones still need to maintain jobs, take care of families, and plan for the future,' said Sally Werner, chief executive officer, Cancer Support Community. 'Today's announcement reduces some of the most onerous requirements that may have previously discouraged patients, particularly those who live far from a treatment center, from seeking the potentially transformational effects of cell therapy. We applaud any and all efforts to continue to break down barriers, reduce time burden on patients and caregivers, and increase uptake of this life-saving therapy." As BMS continues to bring cell therapy to more patients, we are committed to working across the healthcare ecosystem to implement these label updates and continue to design and implement measurable programs to increase uptake and equitable access to cell therapy. For a list of programs and services currently offered to support patients through their BMS cell therapy journey, visit Bristol Myers Squibb: Unlocking the Full Potential of Cell Therapy A pioneer in harnessing the immune system to fight cancer and an established leader in cell therapy, Bristol Myers Squibb is uniquely positioned to unlock the full potential of this technology across blood cancers and within new frontiers, including autoimmune disease. Bristol Myers Squibb is currently the only company with two approved CAR T cell therapies with two distinct targets, available in major markets around the world. Our bold vision for the future is one in which hundreds of thousands of patients can be treated with cell therapy's transformational potential. The building blocks to realize this ambition—a promising and differentiated pipeline, extensive translational and clinical data sets, a deep bench of talent, and robust manufacturing capabilities—are in our cells. We are laser-focused on advancing the field of cell therapy toward a true revolution for patients. Learn more about the science behind cell therapy and ongoing progress at Bristol Myers Squibb here. Breyanzi U.S. FDA-Approved Indications BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have: refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or relapsed or refractory disease after two or more lines of systemic therapy. Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma. adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor. Abecma U.S. FDA-Approved Indication ABECMA (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Breyanzi U.S. Important Safety Information WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids. Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. Cytokine Release Syndrome Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. In clinical trials of BREYANZI, which enrolled a total of 702 patients with non-Hodgkin lymphoma (NHL), CRS occurred in 54% of patients, including ≥ Grade 3 CRS in 3.2% of patients. The median time to onset was 5 days (range: 1 to 63 days). CRS resolved in 98% of patients with a median duration of 5 days (range: 1 to 37 days). One patient had fatal CRS and 5 patients had ongoing CRS at the time of death. The most common manifestations of CRS (≥10%) were fever, hypotension, tachycardia, chills, hypoxia, and headache. Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, diffuse alveolar damage, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). Ensure that 2 doses of tocilizumab are available prior to infusion of BREYANZI. Neurologic Toxicities Neurologic toxicities that were fatal or life-threatening, including immune effector cell-associated neurotoxicity syndrome (ICANS), occurred following treatment with BREYANZI. Serious events including cerebral edema and seizures occurred with BREYANZI. Fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, also occurred. In clinical trials of BREYANZI, CAR T cell-associated neurologic toxicities occurred in 31% of patients, including ≥ Grade 3 cases in 10% of patients. The median time to onset of neurotoxicity was 8 days (range: 1 to 63 days). Neurologic toxicities resolved in 88% of patients with a median duration of 7 days (range: 1 to 119 days). Of patients developing neurotoxicity, 82% also developed CRS. The most common neurologic toxicities (≥5%) included encephalopathy, tremor, aphasia, headache, dizziness, and delirium. CRS and Neurologic Toxicities Monitoring Monitor patients daily for at least 7 days following BREYANZI infusion for signs and symptoms of CRS and neurologic toxicities and assess for other causes of neurological symptoms. Continue to monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 2 weeks after infusion and treat promptly. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. Manage neurologic toxicity with supportive care and/or corticosteroid as needed. Advise patients to avoid driving for at least 2 weeks following infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time. Hypersensitivity Reactions Allergic reactions may occur with the infusion of BREYANZI. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO). Serious Infections Severe infections, including life-threatening or fatal infections, have occurred in patients after BREYANZI infusion. In clinical trials of BREYANZI, infections of any grade occurred in 34% of patients, with Grade 3 or higher infections occurring in 12% of all patients. Grade 3 or higher infections with an unspecified pathogen occurred in 7%, bacterial infections in 3.7%, viral infections in 2%, and fungal infections in 0.7% of patients. One patient who received 4 prior lines of therapy developed a fatal case of John Cunningham (JC) virus progressive multifocal leukoencephalopathy 4 months after treatment with BREYANZI. One patient who received 3 prior lines of therapy developed a fatal case of cryptococcal meningoencephalitis 35 days after treatment with BREYANZI. Febrile neutropenia developed after BREYANZI infusion in 8% of patients. Febrile neutropenia may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad- spectrum antibiotics, fluids, and other supportive care as medically indicated. Monitor patients for signs and symptoms of infection before and after BREYANZI administration and treat appropriately. Administer prophylactic antimicrobials according to standard institutional guidelines. Avoid administration of BREYANZI in patients with clinically significant, active systemic infections. Viral reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. In clinical trials of BREYANZI, 35 of 38 patients with a prior history of HBV were treated with concurrent antiviral suppressive therapy. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines. Prolonged Cytopenias Patients may exhibit cytopenias not resolved for several weeks following lymphodepleting chemotherapy and BREYANZI infusion. In clinical trials of BREYANZI, Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in 35% of patients, and included thrombocytopenia in 25%, neutropenia in 22%, and anemia in 6% of patients. Monitor complete blood counts prior to and after BREYANZI administration. Hypogammaglobulinemia B-cell aplasia and hypogammaglobulinemia can occur in patients receiving BREYANZI. In clinical trials of BREYANZI, hypogammaglobulinemia was reported as an adverse reaction in 10% of patients. Hypogammaglobulinemia, either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion, was reported in 30% of patients. Monitor immunoglobulin levels after treatment with BREYANZI and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement as clinically indicated. Live vaccines: The safety of immunization with live viral vaccines during or following BREYANZI treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during BREYANZI treatment, and until immune recovery following treatment with BREYANZI. Secondary Malignancies Patients treated with BREYANZI may develop secondary malignancies. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing. Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS) Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. Three of 89 (3%) safety evaluable patients with R/R CLL/SLL developed IEC-HS. Time to onset of IEC-HS ranged from 7 to 18 days. Two of the 3 patients developed IEC-HS in the setting of ongoing CRS and 1 in the setting of ongoing neurotoxicity. IEC-HS was fatal in 2 of 3 patients. One patient had fatal IEC-HS and one had ongoing IEC-HS at time of death. IEC-HS is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of IEC-HS should be administered per current practice guidelines. Adverse Reactions The most common adverse reaction(s) (incidence ≥30%) in: LBCL are fever, cytokine release syndrome, fatigue, musculoskeletal pain, and nausea. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, platelet count decrease, and hemoglobin decrease. CLL/SLL are cytokine release syndrome, encephalopathy, fatigue, musculoskeletal pain, nausea, edema, and diarrhea. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, hemoglobin decrease, platelet count decrease, and lymphocyte count decrease. FL is cytokine release syndrome. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, and white blood cell decrease. MCL are cytokine release syndrome, fatigue, musculoskeletal pain, and encephalopathy. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, and platelet count decrease. Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide. Abecma U.S. Important Safety Information WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED CYTOPENIA and SECONDARY HEMATOLOGICAL MALIGNANCIES Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with ABECMA. Do not administer ABECMA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids. Neurologic Toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with ABECMA. Provide supportive care and/or corticosteroids as needed. Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS) including fatal and life-threatening reactions, occurred in patients following treatment with ABECMA. HLH/MAS can occur with CRS or neurologic toxicities. Prolonged Cytopenia with bleeding and infection, including fatal outcomes following stem cell transplantation for hematopoietic recovery, occurred following treatment with ABECMA. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA. Warnings and Precautions: Early Death: In KarMMa-3, a randomized (2:1), controlled trial, a higher proportion of patients experienced death within 9 months after randomization in the ABECMA arm (45/254; 18%) compared to the standard regimens arm (15/132; 11%). Early deaths occurred in 8% (20/254) and 0% prior to ABECMA infusion and standard regimen administration, respectively, and 10% (25/254) and 11% (15/132) after ABECMA infusion and standard regimen administration, respectively. Out of the 20 deaths that occurred prior to ABECMA infusion, 15 occurred from disease progression, 3 occurred from adverse events and 2 occurred from unknown causes. Out of the 25 deaths that occurred after ABECMA infusion, 10 occurred from disease progression, 11 occurred from adverse events, and 4 occurred from unknown causes. Cytokine Release Syndrome (CRS): CRS, including fatal or life-threatening reactions, occurred following treatment with ABECMA. Among patients receiving ABECMA for relapsed refractory multiple myeloma in the KarMMa and KarMMa-3 studies (N=349), CRS occurred in 89% (310/349), including ≥ Grade 3 CRS (Lee grading system) in 7% (23/349) of patients and Grade 5 CRS in 0.9% (3/349) of patients. The median time-to-onset of CRS, any grade, was 1 day (range: 1 to 27 days), and the median duration of CRS was 5 days (range: 1 to 63 days). In the pooled studies, the rate of ≥Grade 3 CRS was 10% (7/71) for patients treated in dose range of 460 to 510 x 10 6 CAR-positive T cells and 5.4% (13/241) for patients treated in dose range of 300 to 460 x 10 6 CAR-positive T cells. The most common manifestations of CRS (greater than or equal to 10%) included pyrexia (87%), hypotension (30%), tachycardia (26%), chills (19%), hypoxia (16%). Grade 3 or higher events that may be associated with CRS include hypotension, hypoxia, hyperbilirubinemia, hypofibrinogenemia, ARDS, atrial fibrillation, hepatocellular injury, metabolic acidosis, pulmonary edema, coagulopathy, renal failure, multiple organ dysfunction syndrome and HLH/MAS. Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS. Of the 349 patients who received ABECMA in clinical trials, 226 (65%) patients received tocilizumab; 39% (135/349) received a single dose, while 26% (91/349) received more than 1 dose of tocilizumab. Overall, 24% (82/349) of patients received at least 1 dose of corticosteroids for treatment of CRS. Almost all patients who received corticosteroids for CRS also received tocilizumab. For patients treated in dose range of 460 to 510 x 10 6 CAR-positive T cells, 76% (54/71) of patients received tocilizumab and 35% (25/71) received at least 1 dose of corticosteroids for treatment of CRS. For patients treated in dose range of 300 to 460 x 10 6 CAR-positive T cells, 63% (152/241) of patients received tocilizumab and 20% (49/241) received at least 1 dose of corticosteroid for treatment of CRS. Monitor patients at least daily for 7 days following ABECMA infusion for signs or symptoms of CRS. Continue to monitor patients for signs and symptoms of CRS for at least 2 weeks after infusion. At the first sign of CRS, institute treatment with supportive care, tocilizumab and/or corticosteroids as indicated. Ensure that a minimum of 2 doses of tocilizumab are available prior to infusion of ABECMA. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time. Neurologic Toxicities: Neurologic toxicities, including immune-effector cell-associated neurotoxicity (ICANS), which may be severe or life-threatening, occurred concurrently with CRS, after CRS resolution, or in the absence of CRS following treatment with ABECMA. In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, CAR T cell-associated neurotoxicity occurred in 40% (139/349), including Grade 3 in 4% (14/349) and Grade 4 in 0.6% (2/349) of patients. The median time to onset of neurotoxicity was 2 days (range: 1 to 148 days). The median duration of CAR T cell-associated neurotoxicity was 8 days (range: 1 to 720 days) in all patients including those with ongoing neurologic events at the time of death or data cut off. CAR T cell-associated neurotoxicity resolved in 123 of 139 (88%) patients and median time to resolution was 5 days (range: 1 to 245 days). One-hundred and thirty four out of 349 (38%) patients with neurotoxicity had CRS. The onset of neurotoxicity during CRS was observed in 93 patients, before the onset of CRS in 12 patients, and after the CRS event in 29 patients. The rate of Grade 3 or 4 CAR T cell-associated neurotoxicity was 5.6% (4/71) and 3.7% (9/241) for patients treated in dose range of 460 to 510 x 10 6 CAR-positive T cells and 300 to 460 x 10 6 CAR-positive T cells, respectively. The most frequent (greater than or equal to 5%) manifestations of CAR T cell-associated neurotoxicity include encephalopathy (21%), headache (15%), dizziness (8%), delirium (6%), and tremor (6%). At the safety update for KarMMa-3 study, one patient developed fatal neurotoxicity 43 days after ABECMA. In KarMMa, one patient had ongoing Grade 2 neurotoxicity at the time of death. Two patients had ongoing Grade 1 tremor at the time of data cutoff. Cerebral edema has been associated with ABECMA in a patient in another study in multiple myeloma. Grade 3 myelitis and Grade 3 parkinsonism have occurred after treatment with ABECMA in another study in multiple myeloma. Monitor patients at least daily for 7 days following ABECMA infusion for signs or symptoms of neurologic toxicities. Continue to monitor patients for signs or symptoms of neurologic toxicities for at least 2 weeks after ABECMA infusion and treat promptly. Rule out other causes of neurologic symptoms. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed. Counsel patients to seek immediate medical attention should signs or symptoms occur at any time. Advise patients to avoid driving for at least 2 weeks following infusion. Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS): In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, HLH/MAS occurred in 2.9% (10/349) of patients. All events of HLH/MAS had onset within 10 days of receiving ABECMA, with a median onset of 6.5 days (range: 4 to 10 days) and occurred in the setting of ongoing or worsening CRS. Five patients with HLH/MAS had overlapping neurotoxicity. The manifestations of HLH/MAS include hypotension, hypoxia, multiple organ dysfunction, renal dysfunction and cytopenia. In KarMMa-3, one patient had Grade 5, two patients had Grade 4 and two patients had Grade 3 HLH/MAS. The patient with Grade 5 HLH/MAS also had Grade 5 candida sepsis and Grade 5 CRS. In another patient who died due to stroke, the Grade 4 HLH/MAS had resolved prior to death. Two cases of Grade 3 and one case of Grade 4 HLH/MAS had resolved. In KarMMa, one patient treated in the 300 x 10 6 CAR-positive T cells dose cohort developed fatal multi-organ HLH/MAS with CRS. In another patient with fatal bronchopulmonary aspergillosis, HLH/MAS was contributory to the fatal outcome. Three cases of Grade 2 HLH/MAS resolved. HLH/MAS is a potentially life-threatening condition with a high mortality rate if not recognized early and treated. Treatment of HLH/MAS should be administered per institutional guidelines. Hypersensitivity Reactions: Allergic reactions may occur with the infusion of ABECMA. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO) in ABECMA. Infections: ABECMA should not be administered to patients with active infections or inflammatory disorders. Severe, life-threatening, or fatal infections occurred in patients after ABECMA infusion. In all patients receiving ABECMA in the KarMMa and KarMMa-3 studies, infections (all grades) occurred in 61% of patients. Grade 3 or 4 infections occurred in 21% of patients. Grade 3 or 4 infections with an unspecified pathogen occurred in 12%, viral infections in 7%, bacterial infections in 4.3%, and fungal infections in 1.4% of patients. Overall, 15 patients had Grade 5 infections (4.3%); 8 patients (2.3%) with infections of pathogen unspecified, 3 patients (0.9%) with fungal infections, 3 patients (0.9%) with viral infections, and 1 patient (0.3%) with bacterial infection. Monitor patients for signs and symptoms of infection before and after ABECMA infusion and treat appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials according to standard institutional guidelines. Febrile neutropenia was observed in 38% (133/349) of patients after ABECMA infusion and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated. Viral Reactivation: Cytomegalovirus (CMV) infection resulting in pneumonia and death has occurred following ABECMA administration. Monitor and treat for CMV reactivation in accordance with clinical guidelines. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against plasma cells. Perform screening for CMV, HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) in accordance with clinical guidelines before collection of cells for manufacturing. Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice. Prolonged Cytopenias: In patients receiving ABECMA in the KarMMa and KarMMa-3 studies, 40% of patients (139/349) experienced prolonged Grade 3 or 4 neutropenia and 42% (145/349) experienced prolonged Grade 3 or 4 thrombocytopenia that had not resolved by Month 1 following ABECMA infusion. In 89% (123/139) of patients who recovered from Grade 3 or 4 neutropenia after Month 1, the median time to recovery from ABECMA infusion was 1.9 months. In 76% (110/145) of patients who recovered from Grade 3 or 4 thrombocytopenia, the median time to recovery was 1.9 months. Five patients underwent stem cell therapy for hematopoietic reconstitution due to prolonged cytopenia. The rate of Grade 3 or 4 thrombocytopenia was 62% (44/71) and 56% (135/241) for patients treated in dose range of 460 to 510 x 10 6 CAR-positive T cells and 300 to 460 x 10 6 CAR-positive T cells, respectively. Monitor blood counts prior to and after ABECMA infusion. Manage cytopenia with myeloid growth factor and blood product transfusion support according to local institutional guidelines. Hypogammaglobulinemia: In all patients receiving ABECMA in the KarMMa and KarMMa-3 studies, hypogammaglobulinemia was reported as an adverse event in 13% (46/349) of patients; laboratory IgG levels fell below 500 mg/dL after infusion in 37% (130/349) of patients treated with ABECMA. Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion occurred in 45% (158/349) of patients treated with ABECMA. Forty-one percent of patients received intravenous immunoglobulin (IVIG) post-ABECMA for serum IgG <400 mg/dL. Monitor immunoglobulin levels after treatment with ABECMA and administer IVIG for IgG <400 mg/dL. Manage appropriately per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis. Use of Live Vaccines: The safety of immunization with live viral vaccines during or after ABECMA treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during ABECMA treatment, and until immune recovery following treatment with ABECMA. Secondary Malignancies: Patients treated with ABECMA may develop secondary malignancies. In KarMMa-3, myeloid neoplasms (four cases of myelodysplastic syndrome and one case of acute myeloid leukemia) occurred in 2.2% (5/222) of patients following treatment with ABECMA compared to none in the standard regimens arm at the time of the safety update. The median time to onset of myeloid neoplasm from ide-cel infusion was 338 days (Range: 277 to 794 days). Three of these five patients have died following the development of myeloid neoplasm. One out of the five cases of myeloid neoplasm occurred after initiation of subsequent antimyeloma therapy. T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing of secondary malignancy. Adverse Reactions: The most common nonlaboratory adverse reactions (incidence greater than or equal to 20%) include pyrexia, CRS, hypogammaglobulinemia, infections – pathogen unspecified, musculoskeletal pain, fatigue, febrile neutropenia, hypotension, tachycardia, diarrhea, nausea, headache, chills, upper respiratory tract infection, encephalopathy, edema, dyspnea and viral infections. Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide. About Bristol Myers Squibb Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at or follow us on LinkedIn, X, YouTube, Facebook and Instagram. Cautionary Statement Regarding Forward-Looking Statements This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include whether Breyanzi (lisocabtagene maraleucel) and Abecma (idecabtagene vicleucel) for the indications described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb's business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2024, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
Hans India
25-06-2025
- Business
- Hans India
RTC staff to stage protests across state on July 4 & 5
APPTD leaders submit a representation to transport commissioner and RTC MD with a list of demands which include promotions to 3,000 RTC employees, recruitment of 10,000 new staff, release of pending DA arrears and 11th PRC arrears, implementation of Retired Employees Medical Scheme among others The Andhra Pradesh Public Transport Department (APPTD) Employees' Union announced on Tuesday that it will stage statewide protests and conduct gate meetings at all 129 RTC depots on July 4 and 5. These demonstrations are a protest against the government's and RTC management's inaction in resolving their pending problems. RTC employees plan to wear red badges at the depots to express their discontent. The decision came during the APPTD state executive body meeting here, where the union discussed its long-standing grievances. The union's state meeting urged the government to immediately resolve critical issues affecting thousands of RTC employees across the state. Union leaders submitted a representation to APPTD commissioner and APSRTC vice-chairman and managing director Ch Dwaraka Tirumala Rao, detailing their demands and asking the RTC management to address them. APPTD Employees' Union president Palisetty Damodara Rao and general secretary G V Narasaiah raised several key demands. They stated that 3,000 RTC employees have been waiting for promotions for over six years and urged the RTC management to secure approval from the state government to grant these promotions. They also pressed the RTC to obtain government approval to recruit 10,000 new staff in the APSRTC and to purchase new buses. This recruitment and fleet expansion, they noted, are essential to support the implementation of the free travel facility for women from August 15, 2025, onwards. The union has also sought release of pending DA arrears and 11th PRC arrears, and immediate settlement of retirement benefits for employees, including the immediate disbursement of gratuity and leave encashment to retired personnel. Furthermore, they demanded that the RTC management implement the Retired Employees Medical Scheme (REMS) according to guidelines issued by the CEO of NTR Vaidya Vidhana Parishat Trust. They also insisted that the RTC procure electric buses directly and hand them over to APSRTC, thereby avoiding the leasing of depots to private operators. Finally, the union urged the RTC to train existing RTC staff to operate new electric buses, restore referral hospital-based medical services under the old system, offer alternative posts to medically unfit employees, and implement pending compassionate appointments.
Boston Globe
06-06-2025
- Health
- Boston Globe
Massachusetts joins three other Democrat-led states asking FDA to remove abortion pill restrictions
Advertisement Abortion pills — particularly mifepristone — have become the focus of legal battles and new legislation seeking to expand or further curtail access to the procedure since the Supreme Court overturned Roe v. Wade in 2022, and with it, the national right to abortion. Thursday's petition comes days after FDA Commissioner Marty Makary said he would conduct a review of the drug, alarming reproductive health advocates who worry the agency is gearing up to further limit access. Get Starting Point A guide through the most important stories of the morning, delivered Monday through Friday. Enter Email Sign Up A spokesperson for the Department of Health and Human Services, which includes the FDA, said HHS Secretary Robert F. Kennedy Jr. had asked Makary to review mifepristone data. The spokesperson added that Makary 'will ensure gold standard science is used while incorporating practical, common-sense considerations to its regulatory processes.' Advertisement A large body of research shows mifepristone, first approved more than two decades ago, is safe and effective. It is used in the majority of abortions in the United States. The Democratic attorneys general asked the FDA to review the restrictions on mifepristone Thursday through a citizen petition submitted to HHS and the FDA. By law, the FDA is required to respond within 180 days of receiving the petition — granting, denying or dismissing it, or justifying why it has not reached a decision on the matter. In the month after a decision, petitioners can ask the FDA to reconsider. After that, they have the option to take the issue to court. The four attorneys general are asking the FDA to remove requirements under its Mifepristone Risk Evaluation and Mitigation Strategy (REMS) program that mandate pharmacy certification, which involves using shippers that provide tracking and patient agreement forms for receiving the drug. They are also asking the FDA to remove prescriber certification requirements, saying the restrictions 'can discourage clinicians from offering it,' according to the petition. To prescribe mifepristone, clinicians have to send a certification form to the pharmacies their patients will visit to receive the drug. That process poses safety risks 'should such lists be leaked or compromised,' the petition says. Those risks for abortion providers are 'all the more prevalent now given the number of states that have criminalized abortion and are seeking to punish providers who have facilitated medication abortions for patients who reside in other states,' the petition says. It alludes to the first-of-its-kind prosecution this year of a New York doctor who allegedly prescribed abortion pills to a patient in Louisiana. Advertisement In a statement Thursday, James said these restrictions discourage many family medicine practices and primary care clinics from stocking or prescribing mifepristone, which particularly impacts 'rural and underserved communities' that have no alternative health-care options. According to the FDA, the Mifespristone REMS program is intended to 'mitigate the risk of serious complications' associated with the drug 'by, among other things, requiring that prescribers have the necessary qualifications to assess whether patients are appropriate candidates for the drug and to provide necessary intervention in case of complications (or have made plans to provide such care through others), ensuring that mifepristone is only dispensed by certified pharmacies or by or under the supervision of certified prescribers, and requiring that patients be informed of the risks of the treatment regimen.' Some Republicans have been pushing the FDA to reassess the safety of mifepristone, based on a study conducted by a conservative think tank that said it found the risk of serious adverse events from taking the drug is much higher than advertised. The study is not peer-reviewed and does not reveal the database used for it. The Washington Post Fact Checker analyzed the study, which was conducted by the Ethics and Public Policy Center, and noted that it found similar rates for the most serious problems associated with abortion, such as sepsis, infection, and emergency-room visits, as are listed on the FDA-approved label of Mifeprex, the brand name for the abortion pill. According to the FDA's prescribing information on mifepristone, fewer than 0.5 percent of people taking the drug with misoprostol to end pregnancy experienced serious adverse reactions. On Thursday, the attorneys general rebuked 'recent attempts to challenge mifepristone's safety using methodologically flawed scientific research papers, noting that several of these papers have been retracted by medical journals.' Advertisement 'The coalition are urging the FDA to use this full review of mifepristone to lift unjustified restrictions and maximize access to this essential medication,' James's statement said.
Yahoo
05-06-2025
- Health
- Yahoo
Blue states call on FDA to expand abortion pill access
Attorneys general of New York, California, New Jersey and Massachusetts are asking the Food and Drug Administration (FDA) to expand access to the abortion pill and remove some 'unnecessary' drug restrictions that have been in place for more than two decades. The joint petition, filed Thursday, comes days after FDA Commissioner Marty Makary committed to reviewing the abortion drug amid pressure from Department of Health and Human Services Secretary Robert F. Kennedy Jr. and some Republican lawmakers. The FDA first approved of the use of mifepristone and misoprostol for an abortion in 2000. Unlike surgical abortions, medication abortions do not need to take place in a clinical setting, and patients are able to take the pills at home. Most abortions in the U.S. are now medication abortions, according to data from the reproductive health and rights group Guttmacher Institute. In 2023, 63 percent of all abortions in the U.S. were medication abortions. The safety of mifepristone has come under increased scrutiny by some Republican lawmakers, citing a flawed study claiming the rate of adverse health events that occur among patients is far higher than previously reported. More than 100 scientific studies have been conducted looking at the safety and efficacy of mifepristone and misoprostol; all of them have found that the drugs are a safe way to terminate a pregnancy. 'Given Mifepristone's 25-year safety record, there is simply no scientific or medical reason to subject it to such extraordinary restrictions,' New York Attorney General Letitia James said. 'The FDA must follow the science and lift these unnecessary barriers that put patients at risk and push providers out of care.' Mifepristone's use is subject to a Risk Evaluation and Mitigation Strategy (REMS) program under the FDA. The attorneys general argue three requirements under the REMS program for the drug should be removed since they pose a burden to patients and health care systems. The first is related to prescriber certification. As part of the REMS program, health care providers who prescribe mifepristone are required to add their names to national and abortion provider lists, which the attorneys general say raise 'serious safety and legal concerns.' The second has to do with patient agreement forms. All patients who want mifepristone — even those using the drug to treat a miscarriage — are required to sign a document stating they are using the drug to end a pregnancy. The third requirement mentioned in the petition is connected to pharmacy certification. As part of mifepristone's REMS program, pharmacies that carry the drug are subject to tracking, shipping and reporting requirements, which the attorneys general argue may 'dissuade' some from carrying the drug. The FDA has yet to reply to a request for comment from The Hill about the petition. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
